Remote therapeutic effectiveness of dry needling and ischemic pressure on the pain intensity and functional disability of upper limb in patients with myofascial pain syndrome
1.Evaluation and comparison of remote therapeutic effects of dry needling and ischemic pressure in patients with myofacial pain syndrome immediately and after 3 sessions.
Design
Two arm parallel group randomised trial with blinded
Settings and conduct
The study is being conducted at Asad abadi Hospital. The inclusion and exclusion criteria are evaluated and written consent is obtained from the participants.Patients are randomized using block. First, the pain pressure threshold and pain intensity were measured in the ipsilateral upper trapezius and extensor carpi radialis longus muscles. Intervention in each group is performed only on the upper trapezius muscle during three sessions with a time interval of one week. End of each session, the pain pressure threshold and pain intensity were recorded in the upper trapezius and extensor carpi radialis longus muscles. Evaluator and patients are blind.
Participants/Inclusion and exclusion criteria
Having neck or shoulder pain, presence of active trigger point in the upper trapezius and latent trigger point in the extensor carpi radialis longus muscle and intensity of pain at least 30 mm on visual analog scale are inclusion criteria.
patients with history of surgery and trauma in the neck or shoulder, infection, or inflammatory edema in the trigger point region, pregnancy and vascular or coagulation disorders will be excluded.
Intervention groups
Intervention group (dry needling): It is performed at the active trigger point of the upper trapezius muscle for 3 sessions with a time interval of one week.
control group (ischemic pressure): It is performed at the active trigger point of the upper trapezius muscle for 3 sessions with a time interval of one week.
Remote therapeutic effectiveness of dry needling and ischemic pressure on the pain intensity and functional disability of upper limb in patients with myofascial pain syndrome
Public title
Remote therapeutic effectiveness of dry needling and ischemic pressure on the pain intensity and functional disability of upper limb in patients with myofascial pain syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient in the age range of 20 to 40 years.
Having neck pain or shoulder pain or both of them.
The presence of active trigger point in the upper trapezius muscle and latent trigger point in the extensor carpi radialis longus muscle.
The intensity of pain should be at least 30 mm on visual analog scale in initial evaluation of active trigger point in the upper trapezius muscle.
Exclusion criteria:
History of surgery in the neck or shoulder or upper extremity
A history of trauma in the recent years.
Radiculopathy in the upper extremity
Kyphosis or severe forward head posture
Involvement with fibromyalgia syndrome
Skin damage, infection, or inflammatory edema in the trigger point region
Pregnancy
sedative drugs consumption before and during treatment
Vascular and coagulation disorders
cancer
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with a sealed envelope:
Two envelopes are prepared with the first and second group titles. Each participant randomly selects one envelope and the envelope number is recorded for the participant. The envelopes are then merged and the next participant selects another envelope from the two envelopes as the previous procedure to complete the randomization process in both groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants will be blind to the mechanism of treatments in each group. examiner is also blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
, Next to the Vahdat Hall, faculty of rehabilitation, IRAN - Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2020-01-20, 1398/10/30
Ethics committee reference number
IR.TBZMED.REC.1398.1154
Health conditions studied
1
Description of health condition studied
Myofascial pain syndrome
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain intensity
Timepoint
Pre intervention, immediately post treatment, 7 and 14 days after first session.
Method of measurement
Visual analogue scale
2
Description
Pain pressure threshold
Timepoint
Pre intervention, immediately post treatment, 7 and 14 days after first session.
Method of measurement
Algometer
3
Description
Disability of the upper limb
Timepoint
before treatment, 7 and 14 days after treatment
Method of measurement
Disability of the Arm Shoulder and Hand (DASH) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Dry needling intervention: In this group, needle enters the active trigger point of the upper trapezius muscle and local twitch response is observed. Then, needle pulls out but does not leave the skin and enters the trigger point again. This is repeated until no local twitch response is detected with 10 manipulation. This treatment is done for 3 sessions with one week interval.
Category
Rehabilitation
2
Description
Control group: Ischemic pressure intervention: In this group, pressure is gradually applied by an algometer disk to the trigger point of upper trapezius muscle of the patient for 90 seconds based on their pain pressure threshold.This technique is repeated 3 to 5 times until the pain and symptoms are resolved. This treatment should be repeated for 3 sessions with an interval of one week.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Asad Abadi hospital, physical therapy clinic
Full name of responsible person
Hakimeh Adigozali
Street address
Bahar street, Asad Abadi hospital
City
Tabriz
Province
East Azarbaijan
Postal code
00000000
Phone
+98 41 3280 1777
Email
adigozalih@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Samiei
Street address
International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, University Street, Tabriz,
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
HakimehAdigozali
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of rehabilitation sciences, Tabriz University of Medical sciences, 29 Bahman Blvd.
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3337 5359
Email
adigozalih@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hakimeh Adigozali
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
faculty of rehabilitation sciences, Tabriz university of Medical Sciences, 29 Bahman Blvd
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3337 5359
Email
adigozalih@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hakimeh Adigozali
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
faculty of rehabilitation sciences, Tabriz university of medical sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3337 5359
Email
adigozalih@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available